Multi-lumen ventricular drainage catheter

ABSTRACT

A shunt includes a housing having an inlet, an outlet and a flow control mechanism disposed within the housing. A ventricular catheter is connected to the inlet of the housing. The catheter has a longitudinal length, a proximal end, a distal end, and an inner lumen extending therethrough. The inner lumen of the catheter includes at least two lumens at the distal end and has only one lumen at the proximal end. The catheter has one slit and aperture corresponding to each of the at least two lumens located at the distal end of the catheter.

FIELD OF THE INVENTION

The present invention relates generally to a shunt and a catheter havinga system for reducing the risk of blockage or obstruction of thecatheter apertures and also increases the ease of revision surgery ifthe catheter is removed.

BACKGROUND OF THE INVENTION

Hydrocephalus is a neurological condition that is caused by the abnormalaccumulation of cerebrospinal fluid (CSF) within the ventricles, orcavities, of the brain. CSF is a clear, colorless fluid that isprimarily produced by the choroid plexus and surrounds the brain andspinal cord. CSF constantly circulates through the ventricular system ofthe brain and is ultimately absorbed into the bloodstream. CSF aids inthe protection of the brain and spinal cord. Because CSF keeps the brainand spinal cord buoyant, it acts as a protective cushion or “shockabsorber” to prevent injuries to the central nervous system.

Hydrocephalus, which affects children and adults, arises when the normaldrainage of CSF in the brain is blocked in some way. Such blockage canbe caused by a number of factors, including, for example, geneticpredisposition, intraventricular or intracranial hemorrhage, infectionssuch as meningitis, head trauma, or the like. Blockage of the flow ofCSF consequently creates an imbalance between the amount of CSF producedby the choroid plexus and the rate at which CSF is absorbed into thebloodstream, thereby increasing pressure on the brain, which causes theventricles to enlarge.

Hydrocephalus is most often treated by surgically inserting a shuntsystem that diverts the flow of CSF from the ventricle to another areaof the body where the CSF can be absorbed as part of the circulatorysystem. Shunt systems come in a variety of models, and typically sharesimilar functional components. These components include a ventricularcatheter which is introduced through a burr hole in the skull andimplanted in the patient's ventricle, a drainage catheter that carriesthe CSF to its ultimate drainage site, and optionally a flow-controlmechanism, e.g., shunt valve, that regulates the one-way flow of CSFfrom the ventricle to the drainage site to maintain normal pressurewithin the ventricles. The ventricular catheter typically containsmultiple holes or apertures positioned along the length of theventricular catheter to allow the CSF to enter into the shunt system, asshown in FIGS. 6 and 7.

Shunting is considered one of the basic neurosurgical procedures, yet ithas the highest complication rate. The most common complication withshunting is obstruction of the system. Although obstruction or cloggingmay occur at any point along the shunt system, it most frequently occursat the ventricular end of the shunt system. While there are several waysthat the ventricular catheter may become blocked or clogged, obstructionis typically caused by growth of tissue, such as the choroid plexus,around the catheter and into the apertures, as shown in FIG. 7. Theapertures of the ventricular catheter can also be obstructed by debris,bacteria, or coagulated blood.

Some of these problems can be treated by backflushing, which is aprocess that uses the CSF present in the shunt system to remove theobstructing matter. This process can be ineffective, however, due to thesmall size of the apertures of the ventricular catheter and due to thesmall amount of flushing liquid available in the shunt system. Othershunt systems have been designed to include a mechanism for flushing theshunt system. For example, some shunt systems include a pumping devicewithin the system which causes fluid in the system to flow withconsiderable pressure and velocity, thereby flushing the system. As withthe process of backflushing, using a built-in mechanism to flush theshunt system can also fail to remove the obstruction due to factors suchas the size of the apertures and the degree and extent to which theapertures have been clogged.

Occluded ventricular catheters can also be repaired by cauterizing thecatheter to remove blocking tissue, thereby reopening existing aperturesthat have become occluded. Alternatively, new apertures can be createdin the catheter. These repairs, however, may be incapable of removingobstructions from the ventricular catheter depending on the location ofthe clogged apertures. Additionally, the extent of tissue growth intoand around the catheter can also preclude the creation of additionalapertures, for example, in situations where the tissue growth covers asubstantial portion of the ventricular catheter. Another disadvantage ofcreating new apertures to repair an occluded ventricular catheter isthat this method fails to prevent or reduce the risk of repeatedobstructions.

Because attempts at flushing or repairing a blocked ventricular catheterare often futile and ineffective, occlusion is more often treated byreplacing the catheter. Although this can be accomplished by removingthe obstructed catheter from the ventricle, the growth of the choroidplexus and other tissues around the catheter and into the apertures canhinder removal and replacement of the catheter. Care must be exercisedto avoid damage to the choroid plexus, which can cause severe injury tothe patient, such as, for example, hemorrhaging. Not only do theseprocedures pose a significant risk of injury to the patient, they canalso be very costly, especially when shunt obstruction is a recurringproblem.

Accordingly, there exists a need for a shunt and a ventricular catheterthat minimizes or eliminates the risk of blockage or obstruction of thecatheter apertures, that increases the ease of revision surgery if thecatheter is removed and reduces the need for repeated repair and/orreplacement.

SUMMARY OF THE INVENTION

The present invention provides a shunt that includes a housing having aninlet, an outlet and a flow control mechanism disposed within thehousing. A ventricular catheter is connected to the inlet of thehousing. The catheter has a longitudinal length, a proximal end, adistal end, and an inner lumen extending therethrough. The inner lumenof the catheter includes at least two lumens at the distal end and hasonly one lumen at the proximal end. The catheter has one aperturecorresponding to each of the at least two lumens located at the distalend of the catheter.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 is a top perspective view of the shunt and ventricular catheteraccording to the present invention;

FIG. 2 is a partial perspective view, with parts broken away, showingthe interior of the ventricular catheter according to the presentinvention;

FIG. 3 is a cross-sectional view taken along lines 3-3 of FIG. 2 andlooking in the direction of the arrows;

FIG. 4 is a cross-sectional view taken along lines 4-4 of FIG. 3 andlooking in the direction of the arrows;

FIG. 4A is a cross-sectional view taken along lines 4A-4A of FIG. 3 andlooking in the direction of the arrows;

FIG. 5 is a cross-sectional view taken along lines 5-5 of FIG. 3 andlooking in the direction of the arrows;

FIG. 6 is a partial top view of a prior art ventricular catheter;

FIG. 7 is cross-sectional view taken along lines 7-7 of FIG. 6 andlooking in the direction of the arrows;

FIG. 8A is a partial top view of the ventricular catheter according tothe present invention; and

FIG. 8B is a partial top view of the ventricular catheter according tothe present invention.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

Referring now to FIGS. 1-5, 8A, 8B and 9 a shunt 10 and a ventricularcatheter 12 in accordance with the present invention is illustrated.

As illustrated in FIG. 1, shunt 10 has a housing 14, which has an inlet16, an outlet 18 and a flow control mechanism disposed therein.Ventricular catheter 12 is connected to inlet 16 of the housing.Catheter 12 has a longitudinal length, a proximal end 20, a distal end22, and an inner lumen 24 extending therethrough. Inner lumen 24 is asingle lumen at proximal end 20 of the catheter and is comprised of twoor more lumens 24 ¹, 24 ¹¹, 24 ¹¹¹, 24 ¹¹¹¹, etc. at the distal end 22of catheter 12. Catheter 12 is preferably made of silicone. In addition,catheter 12 can be impregnated with antimicrobial antibiotics, such asthe CODMAN® BACTISEAL® catheter, which is commercially sold by Codman &Shurtleff, Inc. of Raynham, Mass.

Ventricular catheter 12 has only one aperture 26 at distal end 22 ofcatheter 12 corresponding to each of the lumens 24 ¹, 24 ¹¹¹, 24 ¹¹¹¹,etc. There are preferably between 2 and 7lumens, with only three andfour lumens being shown in the drawing Figures for the sake of brevity.Of course, one skilled in the art would readily know how to make theventricular catheter of the present invention with multiple lumens basedon the present disclosure. Each tapering slit 30 receives cerebrospinalfluid (CSF) when in use. Each aperture 26 has an enlarged opening 28 atthe distal end and transitions from the enlarged opening to a taperingslit 30 at the proximal end of the aperture. In some examples of thepresent invention, for each aperture 26, a portion 32 between theenlarged opening 28 and the tapering slit 30 is a slit 32 of constantthickness. Likewise, in other examples of the present invention, foreach aperture 26, there may be no portion 32 between the enlargedopening 28 and the tapering slit 30. In addition, as illustrated in FIG.9, for each aperture 26, a slit 42 of constant thickness can be disposedbetween the enlarged opening 28 and the proximal end of the aperturewith no tapering slit being utilized. The entire aperture, from theenlarged opening 28 to the proximal end of tapering slit 30 is in fluidcommunication with its respective lumen 24 ¹, 24 ¹¹¹, 24 ¹¹¹¹, etc. Theenlarged opening 28 of each aperture has a smooth concave inner surface34, similar to a spoon shape.

The use of multiple lumens 24 ¹, 24 ¹¹¹, 24 ¹¹¹¹, etc. in accordancewith the present invention help prevent complete occlusion ofventricular catheter 12. In the present invention, ventricular catheter12 can only be completely occluded if all the lumens become blocked. Inaddition, because the transition from multiple lumens to a single lumen24 occurs from about 0.5 to about 3.0 centimeters from the distal end ofthe ventricular catheter, any ingrowth of choroid plexus or ependymaltissue must extend beyond this junction to cause complete occlusion andinterconnection of tissue from multiple apertures, which is unlikely tohappen because of the length the tissue has to grow. The only other waythat the choroid plexus or ependymal tissue would cause a completeocclusion is for the tissue to block each of the multiple lumens 24beyond the slit 30, or to occlude the entire slit 30 and the aperture26.

The slit lumen geometry is preferably tapered or purposely shaped toprovide resistance to fluid flow through the slit that corresponds tothe size of the pathway provided by the slit. The size of the slitopening distributes the pressure gradient over a larger distance andsurface area than conventional ventricular catheters. Diffusing thepressure gradient diminishes the attractive fluid forces and diminishesareas of high fluid flow, thereby lessens the propensity for tissueingrowth.

Referring now to FIGS. 8A and 8B of the present invention, tissueingrowth 36 is illustrated. As can be seen, tissue ingrowth intoaperture 26 will not interconnect with tissue ingrowth from anotherlumen. Thus, should the ventricular catheter 12 need to be removed,catheter 12 will be pulled back out and tissue ingrowth 36 can beremoved from the lumen at the wider end of the taper or at the enlargedopening 28, as illustrated in FIG. 8B. In contrast, in the prior art,tissue ingrowth 36 can be rather difficult to remover from theventricular catheter should the ventricular catheter 12 need to beremoved, as discussed above.

Referring now to FIGS. 2 and 3, ventricular catheter 12, has a bluntdistal end 38 to permit the catheter to be introduced into the brainwithout damaging brain tissue. In addition, an inner concave surface 40is sized to receive a stylet for use in introducing the catheter.

It will be understood that the foregoing is only illustrative of theprinciples of the invention, and that various modifications can be madeby those skilled in the art without departing from the scope and spiritof the invention. All references cited herein are expressly incorporatedby reference in their entirety.

1. A shunt comprising: a housing having an inlet, an outlet and a flowcontrol mechanism disposed therein; a catheter connected to the inlet ofthe housing, the catheter having a longitudinal length, a proximal end,a distal end, and an inner lumen extending therethrough, the inner lumenof the catheter being comprised of at least two lumens at the distal endand being comprised of only one lumen at the proximal end, the catheterhaving an aperture adjacent to the distal end corresponding to each ofthe at least two lumens.
 2. The shunt according to claim 1, wherein eachaperture has an enlarged opening at the distal end and transitions fromthe enlarged opening to a tapering slit at the proximal end of theaperture.
 3. The shunt according to claim 2, wherein a portion of eachaperture between the enlarged opening and the tapering slit is a slit ofconstant thickness.
 4. The shunt according to claim 3, wherein theenlarged opening of each aperture has a smooth concave inner surface. 5.The shunt according to claim 1, wherein the enlarged opening of eachaperture has a smooth concave inner surface.
 6. The shunt according toclaim 1, wherein the inner lumen of the catheter being comprised of atleast three lumens at the distal end.
 7. The shunt according to claim 6,wherein the inner lumen of the catheter being comprised of at least fourlumens at the distal end.
 8. The shunt according to claim 1, wherein thecatheter has only one aperture adjacent to the distal end correspondingto each of the at least two lumens.
 9. A shunt comprising: a housinghaving an inlet, an outlet and a flow control mechanism disposedtherein; a catheter connected to the inlet of the housing, the catheterhaving a longitudinal length, a proximal end, a distal end, and an innerlumen extending therethrough, the inner lumen of the catheter having anaperture that has an enlarged opening at the distal end and transitionsfrom the enlarged opening to a tapering slit at the proximal end of theaperture.
 10. The shunt according to claim 9, wherein a portion of eachaperture between the enlarged opening and the tapering slit is a slit ofconstant thickness.
 11. The shunt according to claim 9, wherein theenlarged opening of each aperture has a smooth concave inner surface.12. The shunt according to claim 9, wherein the enlarged opening of eachaperture has a smooth concave inner surface.
 13. The shunt according toclaim 9, wherein the inner lumen of the catheter being comprised of atleast three lumens at the distal end.
 14. The shunt according to claim13, wherein the inner lumen of the catheter being comprised of at leastfour lumens at the distal end.
 15. The shunt according to claim 9,wherein catheter has only one aperture adjacent to the distal endthereof
 16. The shunt according to claim 9, wherein catheter has atleast two apertures adjacent to the distal end thereof
 17. A ventricularcatheter comprising: the ventricular catheter having a longitudinallength, a proximal end, a distal end, and an inner lumen extendingtherethrough, the inner lumen of the catheter being comprised of atleast two lumens at the distal end and being comprised of only one lumenat the proximal end, the catheter having only one aperture adjacent tothe distal end corresponding to each of the at least two lumens.
 18. Theventricular catheter according to claim 17, wherein each aperture has anenlarged opening at the distal end and transitions from the enlargedopening to a tapering slit at the proximal end of the aperture.
 19. Theventricular catheter according to claim 18, wherein a portion of eachaperture between the enlarged opening and the tapering slit is a slit ofconstant thickness.
 20. The ventricular catheter according to claim 17,wherein the enlarged opening of each aperture has a smooth concave innersurface.
 21. The ventricular catheter according to claim 17, wherein theenlarged opening of each aperture has a smooth concave inner surface.22. The ventricular catheter according to claim 17, wherein the innerlumen of the catheter being comprised of at least three lumens at thedistal end.
 23. The ventricular catheter according to claim 22, whereinthe inner lumen of the catheter being comprised of at least four lumensat the distal end.
 24. A ventricular catheter comprising: theventricular catheter having a longitudinal length, a proximal end, adistal end, and an inner lumen extending therethrough, the catheterhaving an aperture that has an enlarged opening at the distal end andtransitions from the enlarged opening to a tapering slit at the proximalend of the aperture.
 25. The ventricular catheter according to claim 24,wherein a portion of each aperture between the enlarged opening and thetapering slit is a slit of constant thickness.
 26. The ventricularcatheter according to claim 24, wherein the enlarged opening of eachaperture has a smooth concave inner surface.
 27. The ventricularcatheter according to claim 24, wherein the enlarged opening of eachaperture has a smooth concave inner surface.
 28. The ventricularcatheter according to claim 24, wherein the inner lumen of the catheterbeing comprised of at least three lumens at the distal end.
 29. Theventricular catheter according to claim 29, wherein the inner lumen ofthe catheter being comprised of at least four lumens at the distal end.